Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT)
clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&cond=diabetes&spons=mannkind&rcv_s=01%2F01%2F2015&rank=4clinicaltrials.gov/archive/NCT03143816/2017_09_11Changes to NCT03143816 on 2017_09_11
clinicaltrials.gov/archive/NCT03143816/2017_09_11/changesLast updated: September 11, 2017
Estimated Enrollment: 60
Anticipated
Study Start Date:
September 30, 2017Estimated Study Completion Date: October 15, 2017
Estimated
Primary Completion Date:
October 15, 2017 (Final data collection date for primary outcome measure)
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publishing the data after the study, presenting at national scientific meetings
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Phase 2
Changes to NCT02527265 on 2017_08_23
clinicaltrials.gov/archive/NCT02527265/2017_08_23/changesPrimary Outcome Measures:
Number of patients with adverse events [ Time Frame: Baseline to
week 6 ]
Number and percentage of patients with any TEAE, any serious TEAE, any severe TEAE, any TEAE leading to treatment discontinuation, or any TEAE leading to death (only if any occurred) will be summarized by age cohort
Number of patients with hypoglycemic events [ Time Frame: Baseline to
week 6 ]
Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.
Secondary Outcome Measures:
insulin maximum observed concentration (Cmax) [ Time Frame:
1 day ]
PK measures for Afrezza Inhalation Powder as measured by Cmax - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing
insulin time to reach Cmax (tmax) [ Time Frame:
1 day ]
PK measures for Afrezza Inhalation Powder as measured by tmax - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing
insulin area under concentration time curve (AUC) [ Time Frame:
1 day ]
PK measures for Afrezza Inhalation Powder as measured by AUC - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing
Assessment of fumaryl diketopiperazine (FDKP) elimination half-life (t1/2) [ Time Frame:
1 day ]
PK measures for FDKP as measured by t1/2 - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing
Number of patients adhered to dose titration rules [ Time Frame:
30 days ]
Doses for each of 3 days' meals will be titrated based on the median SMBG (120 to 150 minutes post-dose)
Measurement of anti-insulin antibodies [ Time Frame:
Up to 13 months ]
Comparison of
baseline to week 6 and week 52Estimated Enrollment: 46
Anticipated Study Start Date:
September 2017